生物药化学药QC Role/Function Summary:
The Quality Control Manager is responsible for performing and coordinating quality control activities to verify that clinical study execution, outsourced manufacturing/testing activities, study documentation, TMF records, vendor deliverables, and site-level processes are conducted in accordance with established protocols, approved plans, company SOPs, GCP, GMP, and applicable regulatory requirements.
This role is focused on checking execution against established requirements, identifying gaps, documenting observations, supporting issue resolution, and promoting inspection readiness. The Quality Control Manager will perform independent and/or operationally embedded reviews to confirm that approved plans and procedures are being followed consistently and effectively.
The role works closely with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, Supply Chain, CROs, CMOs, contract testing laboratories, study teams, and investigator sites to support compliant execution of clinical-stage pharmaceutical programs.
Responsibilities and Duties:
1. Clinical Study Quality Control
• Review study execution and deliverables to ensure compliance with all study documents, including but not limited to:
o Protocol requirements
o Monitoring plans
o Oversight plans
o Study manuals, including lab manual and pharmacy manuals
o Communication plans
o Safety plans
o GCP
o Regulatory requirements
o Company SOPs
• Conduct quality reviews of study documents to ensure consistency and alignment across documents including:
o Protocols and protocol amendments
o Informed Consent Forms (ICFs)
o Investigator Site Files
o Monitoring Plans
o Vendor Oversight Plans
o Study Manuals
o Recruitment Materials
o Study-specific procedures
• Identify inconsistencies, documentation gaps, missing approvals, version control issues, and deviations from approved processes.
• Provide practical guidance to study teams regarding required corrections, documentation expectations, and compliance with established plans.
2. Study Quality Oversight Visit (SQOV)
• Assist as needed with with Study Quality Oversight Visits (SQOVs) or other visits and/or audits required as part of a clinical trial.
• Work with study teams to ensure issues identified are appropriately documented, tracked, investigated, corrected, and verified.
• Document observations and work with study teams to implement improvements.
• Share lessons learned and quality trends across studies.
3. Quality Issue Management
• Serve as a key Clinical Operations quality resource for study teams.
• Support identification, investigation, documentation, and resolution of quality issues.
• Facilitate root cause analysis for recurring operational quality concerns.
• Track quality issues through resolution and verify effectiveness of corrective actions.
• Escalate significant quality risks to Quality and Clinical Operations leadership when appropriate.
• Collaborate with QA when quality issues require formal CAPA or audit involvement.
4. TMF and Documentation Quality Control
• Support development and implementation of TMF quality standards.
• Perform routine QC review of documents and records in the TMF.
o Perform periodic TMF audits.
• Identify documentation gaps and partner with study teams to close deficiencies.
• Maintain inspection-ready TMFs throughout the study lifecycle.
5. Clinical Operations SOP and Process Management
• Participate in development, review, revision, and implementation of Clinical Operations SOPs, Work Instructions, templates, and guidance documents.
• Ensure operational procedures align with:
o Regulatory requirements
o Industry best practices
o ICH-GCP guidelines
• Identify process gaps and opportunities for operational improvement.
• Lead or support continuous improvement initiatives within Clinical Operations.
• Maintain consistency of operational practices across studies and regions.
• 6. Training and Quality CultureEnsures that study specific training requirements are established.
• Monitors and reports on study specific training compliance.
• Works with study team to drive study specific compliance.
• Promote a proactive quality culture across the Clinical Operations organization.
• Communicate quality trends, lessons learned, and best practices to study teams.
7. Inspection Readiness Support
• Support ongoing inspection readiness activities.
• Conduct routine quality assessments and readiness reviews.
• Assist study teams in preparing for:
o Regulatory inspections
o Sponsor audits
o CRO audits
• Support responses to audit and inspection observations as assigned.
• Monitor completion of actions resulting from inspections and audits.
8. Quality Metrics and Trending
• Develop and monitor Clinical Operations quality metrics.
• Analyze quality trends and recurring compliance issues.
• Prepare periodic quality reports for leadership.
• Recommend process improvements as appropriate.
• Support risk-based quality management initiatives.
Qualifications
• Bachelor’s Degree or above in Life Sciences, Pharmacy, Medicine, Nursing, Public Health, Engineering or other related Scientific disciplines.
• Minimum 6 years of QC experience in the pharmaceutical, biotechnology, or medical device industry.
• Practical experience in one or more of the following areas:
o Clinical Monitoring
o Clinical Trial Management
o Clinical Project Management
o TMF Management
o Vendor Oversight
o Study Quality Oversight
• Experience managing electronic Trial Master Files for multi-center, multi-national clinical trials.
• Experience participating in regulatory inspections, sponsor audits, or inspection readiness activities preferred.
• Demonstrated ability to identify quality risks and drive issue resolution in collaboration with operational teams.
Other Skills and Abilities:
• Proficient in Microsoft Office Suite (Project, PowerPoint, Excel, Word); advanced Excel skills for tracking metrics is required.
• Strong document review and quality assessment skills
• Root cause analysis and problem-solving skills
• Ability to identify operational risks and compliance gaps
• Excellent attention to detail
• Strong organizational and time-management skills
• Effective communication and stakeholder management abilities.
• Strong understanding of ICH guidelines (including E6, Q8, Q9), NMPA regulations, and regulatory guidelines applicable to investigational products and clinical trial.
• Fluent in both Mandarin and English (written and spoken)